APPLICATION
ANDA065194
TYPE
ANDA
ORIGINAL APPROVAL
2004-03-22
LATEST ACTION
2019-08-19
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
CLINDAMYCIN HYDROCHLORIDEPrescription
CLINDAMYCIN HYDROCHLORIDE EQ 300MG BASE · CAPSULE · ORAL
CLINDAMYCIN HYDROCHLORIDEPrescription
CLINDAMYCIN HYDROCHLORIDE EQ 150MG BASE · CAPSULE · ORAL
Approval history
2019-08-19Labeling · Supplement 9 · standardAP
2019-08-19Labeling · Supplement 5 · standardAP
2019-08-19Labeling · Supplement 8 · standardAP
2019-08-19Labeling · Supplement 6 · standardAP
2019-08-19Labeling · Supplement 10 · standardAP
2012-02-10Labeling · Supplement 4AP
2006-05-10Labeling · Supplement 2AP
2005-11-14Labeling · Supplement 1AP
2004-03-22OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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